CHANGING THE WAY MEDICINES ARE CREATED TO BEAT COVID-19 AND FUTURE PANDEMICS AND ENSURE WE MAKE DRUGS PEOPLENEED, NOT JUST WHAT MAKES THE MOST PROFIT.

New initiative aims to return to days where patients came first, and physicians led the charge

A panel of eminent healthcare experts (see APPENDIX) have come together to change the way medicines are created, spurred on by the industry’s chaotic response to the CoViD-19 pandemic which has revealed disjointed and chaotic supply chains, over-reliance on overseas products and raw materials, a reluctance to work with UK businesses, inadequate forward planning, duplicated and sometimes flawed clinical trials, chronic PPE shortages compounded by breakdown of transport links and an inability for government to comprehend the scale of use; even the manipulation of statistics to massage figures. These have drawn attention to a medicines (pharmaceuticals) system that for many years has put profits before benefits and is now on life-support

The problem starts when molecules can be patented then shelved to prevent competition. Drug discovery uses a ‘shotgun’ approach, making trials onerous, expensive and time consuming. Promising drugs are held back to maximise profits from existing products. Only a handful of medics are involved in a drug development process, so healthcare professionals only see a new drug when their drug rep calls. They have no opportunity to give guidance on what patients actually need.

Difficulties like these are compounded by major pharma companies outsourcing nearly all their product development, manufacturing and distribution capability overthe last 40 years, while moving offshore (mainly China) to save on the cost of their raw materials and intermediate products.

The problems are epitomised by the hundreds of companies currently competing against each other to manufacture a vaccine, with huge financial gains for the winner. These mRNA ‘fast track’ vaccines using assembled genetic code rather than immobilised virus originated in early 1990s, but have never been approved for use in humans due to safety concerns and poor profit potential. No-one has ever succeeded before in developing a coronavirus vaccine, despite the huge profit to be made with a cure for the common cold. No-one can predict whether a vaccine will emerge that may or may not be of use, or one that if rushed, may do more harm than good. Yet government strategy seems to be reliant on such a vaccine being successful.

Recently the UN Chief, Antonio Guterres called for global collaboration within the pharmaceutical industry, stating – “We need an ambitious effort to ensure that international stakeholders operate through a harmonized, integrated and leveraged approach to maximize the speed and scale needed for the universal deployment of such a vaccine by the end of 2020.”

The time is right for our panel of eminent healthcare experts to facilitate change and breathe new life into an ailing system.

How will we achieve this?

Hedley Rees, CEO of life science supply chain management consultancy, PharmaFlow, and Wiley author on the topic, says: I completely agree with the UN Chief Guterres.

“We want to start by showing that the current business models have not helped the majority in the past; why are we in a race and not helping each other”?

We will create educational packages for students wanting to apply their STEM skills and pursue a career in medicines starting at GCSE level. Then we have packages through A-Level, undergraduate, graduate, up to existing medics, scientists, pharmacists and engineers – we aim to instil a culture of collaboration and integration into this crucially important industry.

We will lobby decision-makers, government, learned bodies and trade organisations. We will explain how to unravel complex supply chains, highlighting the focus on patents not patients, and the harm and damage this is causing. We will show them a completely different way that has a proven track record of working.

Hedley aims to bring back the old ways of medicinal discovery, where patients were put first, alongside the input from medics with all the benefits of modern science and technologies – erasing the ‘blockbuster for profit’ model that is showing less and less returns, and replacing it with tried and tested methodology for providing drugs that target real illnesses, diseases and ailments.

The team of experts have proven track records in all aspects of pharma, including materials, manufacturing, clinical trials, testing, quality and marketing, as well as experience of expert systems, production control, the latest technologies etc., and can drive the project in whatever direction is most appropriate to help pharmaceutical companies make medicines that benefit society and by doing so become major income streams.

Using Kickstarter as the funding mechanism, Hedley aims to raise £35,000. This will provide him and his highly experienced team the funds and the time to create digital educational packages that will take medicines back to the future, to the days of collaboration, but with new technologies, knowledge and ways of thinking, The Kickstarter crowdfund has been launched to help bring this project to life.

About Hedley Rees, CEO PharmaFlow, author of Wiley’s Supply Chain Management in the Drug Industry; Delivering Patient Value for Pharmaceuticals and Biologics and Taming the Big Pharma Monster, leader of this important initiative.

Hedley Rees is an author and CEO of PharmaFlow Limited, a UK based consultancy specialising in operations and supply chain management within life science.

His skill set covers the range of competencies from strategic procurement, production and inventory control, distribution logistics, information systems and improvement.

Hedley is a zealous advocate of the regulatory modernisation frameworks of FDA’s 21st Century Modernization (Janet Woodcock MD) and the International Council for Harmonisation (ICH). He graduated from the University of Wales as a production engineer and holds an Executive MBA from Cranfield University School of Management. Hedley lives in Bridgend, South Wales.

The image below highlights the principles. Instead of the current three step process of discovery, development and final production, we move to a two-step process – prototyping and final production:

Prototyping is used in every other industry except medicines. In aviation, it’s wind tunnels and flight simulators. There’s no appetite to do the same for medicines.

We want to change that with STEM – Science, Technology, Engineering and Maths. At the core of STEM is integration of all the skills required to bring products to market. This is the missing ingredient we want to put back in the pot.

WHAT ARE THE UNDERPINNING PRINCIPLES?

People treated as individuals with prevention, diagnostic and therapy needs.

If medicine needed, healthcare professionals (HCPs) involved at the start.

Involve all the professions needed to develop a medicine AT THE BEGINNING.

Remove the brick-wall between discovery and development, to make it one group titled ‘DESIGN’.

Group develops prototypes to be tested for suitability for patients and HCPs.

Supply chains should be designed strategically, making them simple and streamlined.

HOW DO WE KNOW IT WILL WORK?

The medicines’ industry wasn’t always like this. In 1950, the then head of one of the world’s largest pharmaceutical companies, George W Merck, famously said “We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been!” We rest our case.

This is a confused spaghetti of a value chain where failure rates are appallingly high. From 250 patented compounds that enter the development pipeline, just one medicine is approved for sale, at a cost of £/$ billions, mainly made up of the cost of the failures…

NO WONDER MEDICINES ARE SO EXPENSIVE!

We believe that if we make it simpler, re-integrate many of the activities via vertical integration, bring in the right people – such as doctors and their patients. We will ask them what they need to take us back to when medicines were created because they were needed, not because company X has patented X number of molecules and needs to find a return on their investment.

Hence our hashtag – #PatientsNotPatents – look out for it on Twitter.

HOW PATENT LAW SHOULD CHANGE

If we ask for more evidence of a compound’s suitability for the rigours of commercialisation BEFORE a patent is awarded, greater collaboration would be necessary to collect that evidence

Examples of some of the questions to ask would be: “Are the compound’s characteristics compatible with manufacturing scale up?” Has maximum use of predictive technologies been applied BEFORE testing in animals and humans (ex vivo)?” “Are suppliers across the value chain fully competent to undertake the journey to regulatory approval?” There are many more that need to be asked to be sure the compound has a fighting chance of getting to patients.

Along with greater proof of potential success pre-patent award, if the industry starts to re-integrate new product development activities currently outsourced, then we could move to this much simpler, and in our opinion more beneficial, method of working (it used to be like this pre-blockbuster era):

Life could be so much simpler:

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